510(k) K945613 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT
| Applicant | Howmedica Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent for Some Indications, Mar 6, 1995 |
| Received | Nov 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945613
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.